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Obesity is a chronic disease characterized by the excessive accumulation of fat in body and it continues to be a major public health problem worldwide. Treatment options for obesity include lifestyle modification, pharmacotherapy and bariatric surgery. Bariatric surgery is a highly effective treatment for obesity and results in rapid and sustained weight loss. Also, it significantly alters gut microbiota composition and function. A very low-calorie diet (VLCD) is a rapid weight loss program which calorie intake is severely restricted (< 800 kcal/day). It has been shown to be very effective to induce rapid weight loss and result in comorbidities resolution similar to bariatric surgery. Therefore, this study was aimed to study the effects of 12-week VLCD compare to bariatric surgery (Laparoscopic Roux-en-Y gastric bypass (LRYGB) or Laparoscopic Sleeve Gastrectomy (LSG)) on weight loss, body composition, gut microbiota pattern and other metabolic parameters.
The study will include obese patients (body mass index; BMI ≥ 37.5 kg/m2 or BMI ≥ 32.5 kg/m2 with comorbidities), aged 15-65 years at Ramathibodi Hospital, Thailand. The VLCD group will received total diet replacement for 12 weeks and the bariatric surgery group will undergo LRYGB or LSG. Study participants in both groups will be matched according to their age, sex, body mass index (BMI) and diabetic status. Body weight reduction and body composition, gut microbiota pattern, liver stiffness and steatosis, glycemic and other metabolic parameters (glucose, insulin, c-peptide, lipid profile, liver function test, kidney function test, complete blood count, electrolyte blood test, thyroid function tests, serum ketone and adiponectin), health-related quality of life, depression score and twenty-four-hour diet recall and physical activity will be assessed at baseline and at month 1, 3, 6, 9 and 12.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Very low-calorie diet | Experimental | Patients in the very low-calorie diet group will be prescribed a very low-calorie diet (meal replacement) for 12 weeks, then the patients will be monitored up to 1 year |
|
| Bariatric surgery | Experimental | Patients in the bariatric surgery group will be undergone bariatric surgery LRYGB and will be follow-up according the current guideline |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Very low-calorie diet | Other | Meal replacement (800 kcal/day, protein 90 g/day) |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in body weight | Weight in kg | From baseline to 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Body Composition | The percentage of body fat and skeleton muscle mass | From baseline to 12 weeks |
| Gut microbiota pattern | Measured by 16S ribosomal RNA (rRNA) gene sequencing on the fecal samples |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Medicine Ramathibodi Hospital Mahidol University | Bangkok | 10400 | Thailand |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32753461 | Background | Wharton S, Lau DCW, Vallis M, Sharma AM, Biertho L, Campbell-Scherer D, Adamo K, Alberga A, Bell R, Boule N, Boyling E, Brown J, Calam B, Clarke C, Crowshoe L, Divalentino D, Forhan M, Freedhoff Y, Gagner M, Glazer S, Grand C, Green M, Hahn M, Hawa R, Henderson R, Hong D, Hung P, Janssen I, Jacklin K, Johnson-Stoklossa C, Kemp A, Kirk S, Kuk J, Langlois MF, Lear S, McInnes A, Macklin D, Naji L, Manjoo P, Morin MP, Nerenberg K, Patton I, Pedersen S, Pereira L, Piccinini-Vallis H, Poddar M, Poirier P, Prud'homme D, Salas XR, Rueda-Clausen C, Russell-Mayhew S, Shiau J, Sherifali D, Sievenpiper J, Sockalingam S, Taylor V, Toth E, Twells L, Tytus R, Walji S, Walker L, Wicklum S. Obesity in adults: a clinical practice guideline. CMAJ. 2020 Aug 4;192(31):E875-E891. doi: 10.1503/cmaj.191707. No abstract available. | |
| 30814686 |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D050110 | Bariatric Surgery |
| ID | Term |
|---|---|
| D049088 | Bariatrics |
| D000073319 | Obesity Management |
| D013812 | Therapeutics |
| D013514 | Surgical Procedures, Operative |
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Three groups of patients will be recruited at obesity clinic, Ramathibodi Hospital Mahidol University, Bangkok, Thailand. One group will take part in the very low-calorie diet (VLCD). One group will be undergone bariatric surgery (LRYGB or LSG)
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| Bariatric surgery |
| Procedure |
Bariatric surgery will be performed by single surgeon at Ramathibodi Hospital Mahidol University, Thailand. Postoperative diet progression according to the current guideline will be prescribed from early post-op period to 1 year after surgery |
|
| From baseline to 12 weeks |
| Liver stiffness | Measured by FibroScan® instrument | From baseline to 12 weeks |
| Liver steatosis | Measured by FibroScan® instrument | From baseline to 12 weeks |
| Blood pressure | Systolic and diastolic blood pressure | From baseline to 12 weeks |
| Fasting plasma glucose | Measured in mg/dl | From baseline to 12 weeks |
| Hemoglobin A1c | Measured in % | From baseline to 12 weeks |
| Fasting insulin | Measured in μIU/l | From baseline to 12 weeks |
| Insulin resistance | Measured by the homeostatic model of insulin resistance (HOMA-IR) | From baseline to 12 weeks |
| Triglyceride | Measured in mg/dl | From baseline to 12 weeks |
| Total cholesterol | Measured in mg/dl | From baseline to 12 weeks |
| LDL-cholesterol | Measured in mg/dl | From baseline to 12 weeks |
| HDL-cholesterol | Measured in mg/dl | From baseline to 12 weeks |
| Health-related quality of life | Measured by the EQ-5D-5L questionnaire | From baseline to 12 weeks |
| Depression | Measured by the PHQ-9 questionnaire | From baseline to 12 weeks |
| Background |
| Bluher M. Obesity: global epidemiology and pathogenesis. Nat Rev Endocrinol. 2019 May;15(5):288-298. doi: 10.1038/s41574-019-0176-8. |
| 33178196 | Background | Scheithauer TPM, Rampanelli E, Nieuwdorp M, Vallance BA, Verchere CB, van Raalte DH, Herrema H. Gut Microbiota as a Trigger for Metabolic Inflammation in Obesity and Type 2 Diabetes. Front Immunol. 2020 Oct 16;11:571731. doi: 10.3389/fimmu.2020.571731. eCollection 2020. |
| 27440168 | Background | Shao Y, Ding R, Xu B, Hua R, Shen Q, He K, Yao Q. Alterations of Gut Microbiota After Roux-en-Y Gastric Bypass and Sleeve Gastrectomy in Sprague-Dawley Rats. Obes Surg. 2017 Feb;27(2):295-302. doi: 10.1007/s11695-016-2297-7. |
| 29221645 | Background | Lean ME, Leslie WS, Barnes AC, Brosnahan N, Thom G, McCombie L, Peters C, Zhyzhneuskaya S, Al-Mrabeh A, Hollingsworth KG, Rodrigues AM, Rehackova L, Adamson AJ, Sniehotta FF, Mathers JC, Ross HM, McIlvenna Y, Stefanetti R, Trenell M, Welsh P, Kean S, Ford I, McConnachie A, Sattar N, Taylor R. Primary care-led weight management for remission of type 2 diabetes (DiRECT): an open-label, cluster-randomised trial. Lancet. 2018 Feb 10;391(10120):541-551. doi: 10.1016/S0140-6736(17)33102-1. Epub 2017 Dec 5. |
| 30918654 | Background | Umphonsathien M, Prutanopajai P, Aiam-O-Ran J, Thararoop T, Karin A, Kanjanapha C, Jiamjarasrangsi W, Khovidhunkit W. Immediate and long-term effects of a very-low-calorie diet on diabetes remission and glycemic control in obese Thai patients with type 2 diabetes mellitus. Food Sci Nutr. 2019 Feb 11;7(3):1113-1122. doi: 10.1002/fsn3.956. eCollection 2019 Mar. |
| 32546361 | Background | Lane M, Howland G, West M, Hockey M, Marx W, Loughman A, O'Hely M, Jacka F, Rocks T. The effect of ultra-processed very low-energy diets on gut microbiota and metabolic outcomes in individuals with obesity: A systematic literature review. Obes Res Clin Pract. 2020 May-Jun;14(3):197-204. doi: 10.1016/j.orcp.2020.04.006. Epub 2020 Jun 13. |
| 28916564 | Background | Guo Y, Huang ZP, Liu CQ, Qi L, Sheng Y, Zou DJ. Modulation of the gut microbiome: a systematic review of the effect of bariatric surgery. Eur J Endocrinol. 2018 Jan;178(1):43-56. doi: 10.1530/EJE-17-0403. Epub 2017 Sep 15. |
| 25710027 | Background | Damms-Machado A, Mitra S, Schollenberger AE, Kramer KM, Meile T, Konigsrainer A, Huson DH, Bischoff SC. Effects of surgical and dietary weight loss therapy for obesity on gut microbiota composition and nutrient absorption. Biomed Res Int. 2015;2015:806248. doi: 10.1155/2015/806248. Epub 2015 Feb 1. |
| 29849617 | Background | Castaner O, Goday A, Park YM, Lee SH, Magkos F, Shiow STE, Schroder H. The Gut Microbiome Profile in Obesity: A Systematic Review. Int J Endocrinol. 2018 Mar 22;2018:4095789. doi: 10.1155/2018/4095789. eCollection 2018. |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |